Enhanced Safety Aesthetic Laser System

Scilex

Status

Unknown

Conditions

Hypertrichosis

Telangiectases

Hirsutism

Rhytides

Treatments

Device: Peterio

Study type

Interventional

Funder types

Industry

Identifiers

NCT00495443

Peterio-06

Details and patient eligibility

About

The purpose of this study is to determine whether a new laser system provides better safety and efficacy than existing lasers in popular cosmetic procedures such as hair removal, treatment of cosmetically disturbing vascular lesions and rhytides.

Full description

Cosmetic lasers are a well-established, popular modality for removal of unwanted hair, treatment of all types of vascular lesions, including hemangiomas, port wine stains, and a variety of telangiectases as well as facial rhytides reduction. The existing lasers are based on a wavelength that is specifically absorbed by the chromophore found in the target such as hair follicle, where the energy is converted to heat resulting in a thermal injury. However, the lasers for cosmetic treatments are not without limitations. A laser based long-term hair removal treatment is based on thermal destruction of the hair shaft and follicle using wavelengths that are specifically absorbed by the pigment melanin found in the hair follicle. The heating of hair follicle is done through heat dissipation from the hair shaft. One of the significant limitations of this approach is the fact that the epidermis through which the light energy must penetrate is rich in melanin and therefore absorbs a major portion of the energy, resulting in inadequate heating of the hair follicles. Similar problem exists when targeting other chromophores such as hemoglobin or water. The purpose of the study is an evaluation of safety and efficacy of a new laser based device.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 75 years old
Fitzpatrick skin types I to VI
Unwanted hair or/and
Aesthetically disturbing vascular lesions or/and
Facial rhytides

Exclusion criteria

Age below 18 or above 75 year old.
Use of photosensitive medications
Photosensitive diseases
Active infection of any type and active infection or or a history of Herpes Simplex in the treated site
Exposure to sun or artificial tanning during the last 3-4 weeks
For treatment of facial rhytides- surgical or nonsurgical facial procedure (i.e., laser skin resurfacing, dermabrasion, phenol peel, nonablative laser, or temporary/permanent filler (e.g., collagen, fat, hyaluronic acid injections)